Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
Purpose
The purpose of this study is to assess the effect of pioglitazone on stress- and alcohol-related measures in treatment-seeking individuals with alcohol use disorder (AUD) and elevated levels of stress and anxiety.
Condition
- Alcohol Use Disorder
Eligibility
- Eligible Ages
- Between 21 Years and 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- treatment-seeking individuals diagnosed with AUD diagnostic statistical manual 5 (DSM-5) - fluent in English - past month excessive alcohol use (>7 drinks/week for woman, >14 drinks/week for men, >3 drinks/occasion for women>4 drinks/occasion for men)14 - baseline Hamilton Anxiety Rating Scale (HAM-A) or Perceived Stress Scale (PSS) core indicative of mild to moderate anxiety (score 8 to 23) or moderate stress (score 14 to 26), respectively - increase in alcohol craving following the baseline stress reactivity assessment.
Exclusion Criteria
- Individuals will be excluded for exhibiting severe scores on the HAM-A, PSS, or post-traumatic (PTSD) checklist (PCL-5) at the discretion of the admitting physician - physical dependence on alcohol Alcohol Use Disorders Inventory (AUDIT) score indicative of severe alcohol dependence (≥13 for women, ≥15 for men) - greater than mild substance use disorder on drugs other than alcohol, nicotine, and marijuana - contraindications for taking pioglitazone; medical conditions contraindicating pioglitazone pharmacotherapy or taking contraindicated medications - be pregnant, nursing, or planning on becoming pregnant during the course of the study - have any other illness, condition, or use of medications, which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Pioglitazone |
|
|
Placebo Comparator Placebo |
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More Details
- Status
- Terminated
- Sponsor
- The University of Texas Health Science Center, Houston